Our equipment qualification approach meticulously adheres to established industry standards such as GAMP, ISPE, and ASTM E2500. We emphasize rigorous validation of critical aspects affecting end- product quality, tailoring our activities and documentation to align closely with customer specifications, considering both risk levels and process complexity. This targeted approach ensures comprehensive compliance with regulatory requirements while optimizing resource efficiency. By prioritizing high-risk areas and maintaining robust documentation throughout the validation process, we guarantee the reliability and integrity of our pharmaceutical and biopharmaceutical manufacturing processes, fostering confidence in the quality and safety of our end products within the highly regulated healthcare industry.
